NCT00468988

Brief Summary

Compare the effect of Xalatan with benzalkonium chloride on the ocular surface to those effects observed with Travatan Z without benzalkonium chloride after a single dose

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

May 25, 2012

Status Verified

May 1, 2012

Enrollment Period

2 months

First QC Date

May 2, 2007

Last Update Submit

May 23, 2012

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Tear Break Up Time

    Day

Secondary Outcomes (1)

  • Safety

    Onset

Interventions

Travatan® ZDRUG
Xalatan®DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma

You may not qualify if:

  • Age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando

Orlando, Florida, 32801, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Mark Jasek, PhD

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2007

First Posted

May 3, 2007

Study Start

May 1, 2007

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

May 25, 2012

Record last verified: 2012-05

Locations

US(1)